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This single center study will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the iliac crest in healthy adult volunteers. The study will evaluate the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.
This single center study will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the posterior iliac crest of healthy adult volunteers for bone marrow aspiration specimen collection. The study will evaluate the quality of specimen yield of the devices, subject reported level of pain with needle insertion and aspiration, and time from needle/periosteum contact to needle insertion and to sample acquisition. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and power ported needles. Subjects were randomized for which device procedure was performed first. The second procedure was performed using the other device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: First Procedure: Jamshidi Manual Standard Device | Other | The Jamshidi manual standard device procedure will be performed first. The OnControl Powered Ported device procedure will be performed second. |
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| Group 2: First Procedure OnControl Powered Ported Device | Other | The OnControl power ported device procedure will be performed first. The Jamshidi manual standard device procedure will be performed second. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jamshidi Manual Standard Device | Device | Jamshidi Manual Standard Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device | The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK)
Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
| analyzed and results received within 30 days of Day 1 procedures |
| Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device | The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK)
Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
| analyzed and results received within 30 days of Day 1 procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Pain With Needle Insertion- Jamshidi Manual Standard Device | Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Therapy and Research LLC. | San Antonio | Texas | 78217 | United States |
All subjects received both study arms by receiving bilateral bone marrow aspiration from the iliac crest (right side and left side) using the Jamshidi manual standard device and the OnControl power ported aspiration needle device. Subjects were randomized to determine which device procedure was performed first and were assigned to Group 1 or Group 2.
15 healthy adults were recruited to receive bilateral bone marrow aspiration procedures, one procedure using the Jamshidi Manual Standard Device and one procedure using the OnControl Powered Ported Device.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: First Procedure Jamshidi Manual Standard Device | For the first procedure, the Jamshidi manual standard device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The OnControl Powered Ported device procedure will be performed second using the other iliac crest. |
| FG001 | Group 2: First Procedure OnControl Powered Ported Device | For the first procedure, the OnControl power ported device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The Jamshidi Manual Standard Device procedure will be performed second using the other iliac crest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Procedure |
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| Second Procedure |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: First Procedure Jamshidi Manual Standard Device | For the first procedure, the Jamshidi manual standard device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The OnControl Powered Ported device procedure will be performed second using the other iliac crest. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device | The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK)
Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
| One subject in Group 1 did not complete the unilateral bone marrow aspiration procedure using the Jamshidi Manual Standard Device due to the inability to insert the device into the bone marrow to complete the procedure. Therefore only 14 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | analyzed and results received within 30 days of Day 1 procedures |
from the day of the procedure until 7 days following the procedure
Subjects were contacted by phone to ask if they have experienced any adverse events at 3 time points post-procedure: 24 hours post (+/- 8 hours), 48 hours post (+/- 8 hours), and 7 days+/- 1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Jamshidi Manual Standard Device | Subjects who received the Jamshidi Manual Standard Device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at procedure site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subjects reported pain at the bone marrow aspiration procedure site (iliac crest). Jamshidi Manual Standard Device: 4 iliac crests - 2 right side and 2 left side. OnControl Powered Ported Device: 2 iliac crests - 2 right side and 0 left side. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Puga | Teleflex | tatiana.puga@teleflex.com |
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Subject were randomized to determine which device procedure was performed first. Subjects randomized to Group 1 received the Jamshidi Manual Standard device procedure first and the OnControl Powered Ported device procedure second. Subjects ranomized to Group 2 received the OnControl Powered Ported device procedure first and the Jamshidi Manual Standard device procedure second.
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| OnControl Powered Ported Device | Device | OnControl Powered Ported Device |
|
| Day 1 at time of procedure |
| Level of Pain With Needle Insertion- OnControl Power Ported Device | Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | Day 1 at time of procedure |
| Level of Pain With Aspiration - Jamshidi Manual Standard Device | Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | 1 Day at time of the procedure |
| Level of Pain With Aspiration - OnControl Power Ported Device | Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | 1 Day at time of the procedure |
| Time to Insertion - Jamshidi Manual Standard Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space | 1 Day, during procedure |
| Time to Insertion - OnControl Power Ported Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space | 1 Day, during procedure |
| Time for Aspirate Collection - Jamshidi Manual Standard Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition | 1 Day, during procedure |
| Time for Aspirate Collection - OnControl Power Ported Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition | 1 Day, during procedure |
| Left Iliac Crest |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Group 2: First Procedure OnControl Powered Ported Device | For the first procedure, the OnControl power ported aspiration needle device will be used to perform unilateral bone marrow aspiration from one iliac crest (left side or right side) of each subject. Whether the right or left iliac crest was used was determined by random assignment. The Jamshidi Manual Standard Device procedure will be performed second using the other iliac crest. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Secondary | Level of Pain With Needle Insertion- Jamshidi Manual Standard Device | Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | Group 1: One subject in Group 1 did not complete the unilateral bone marrow aspiration procedure using the Jamshidi Manual Standard Device due to the inability to insert the device into the bone marrow to complete the procedure; for another subject in Group 1 the pain score was not captured. Group 2: For one subject in Group 2 the pain score was not captured. Therefore only 12 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Day 1 at time of procedure |
|
|
|
| Secondary | Level of Pain With Needle Insertion- OnControl Power Ported Device | Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | Posted | Mean | Standard Deviation | units on a scale | Day 1 at time of procedure |
|
|
|
| Secondary | Level of Pain With Aspiration - Jamshidi Manual Standard Device | Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | One subject in Group 1 did not complete the unilateral bone marrow aspiration procedure using the Jamshidi Manual Standard Device due to the inability to insert the device into the bone marrow to complete the procedure. Therefore only 14 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | 1 Day at time of the procedure |
|
|
|
| Secondary | Level of Pain With Aspiration - OnControl Power Ported Device | Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst. Higher numbers indicate greater pain. | Posted | Mean | Standard Deviation | units on a scale | 1 Day at time of the procedure |
|
|
|
| Primary | Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device | The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK)
Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
| Posted | Mean | Standard Deviation | units on a scale | analyzed and results received within 30 days of Day 1 procedures |
|
|
|
| Secondary | Time to Insertion - Jamshidi Manual Standard Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space | One subject in Group 1 did not complete the unilateral bone marrow aspiration procedure using the Jamshidi Manual Standard Device due to the inability to insert the device into the bone marrow to complete the procedure. Therefore only 14 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | seconds | 1 Day, during procedure |
|
|
|
| Secondary | Time to Insertion - OnControl Power Ported Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space | For one subject in Group 2 the time to insertion was not captured. Therefore only 14 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | seconds | 1 Day, during procedure |
|
|
|
| Secondary | Time for Aspirate Collection - Jamshidi Manual Standard Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition | One subject in Group 1 did not complete the unilateral bone marrow aspiration procedure using the Jamshidi Manual Standard Device due to the inability to insert the device into the bone marrow to complete the procedure. Therefore only 14 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | seconds | 1 Day, during procedure |
|
|
|
| Secondary | Time for Aspirate Collection - OnControl Power Ported Device | Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition | For one subject in Group 2 the time for aspirate collection was not captured. Therefore only 14 are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | seconds | 1 Day, during procedure |
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| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | OnControl Powered Ported Device | Subjects who received the OnControl Powered Ported Device. | 0 | 15 | 0 | 15 | 2 | 15 |
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| Particle Crush Smears Score |
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| Clot Sections Score |
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